JP6799053B2 - Systems, devices, and methods for delivering biomaterials for fracture fixation - Google Patents

Description

The present invention relates to a system and device for delivering a fracture-fixing biomaterial and to a method for delivering a fracture-fixing biomaterial, including augmented fixation.

In current standard methods for delivering bone void substitutes (“biomaterials”) such as injectable calcium phosphate cement, the user (typically a surgeon) should work within a comfortable time frame. I can't. Currently, well-known systems require manual mixing of biomaterials before loading and delivering into a syringe method device. This manual mixing process initiates the process of curing the biomaterial, allowing the surgeon to place the biomaterial himself in a well-known delivery system and quickly (often within 2 minutes) the material at the site of implantation. It has the serious drawback of having only a very limited time frame (sometimes around 120 seconds) of delivery. These well-known systems create difficult situations during surgery, resulting in inappropriate or restricted delivery of biomaterial injections.

Premixed cement has recently become available to overcome the above difficulties. However, what is currently available for a wide range of trauma and orthopedic conditions is not desirable. This is because it takes a long time to fully cure and / or once the dispensing process is initiated, the entire injection of premixed cement must be delivered immediately. Again, these well-known systems create difficult situations during surgery, resulting in inappropriate or restricted delivery of biomaterial injections.

An object of the present invention is to alleviate the drawbacks of conventional techniques.

The features of the present invention are described in the claims attached to the present invention. Advantageous features are included in the dependent claims.

The present invention is highly effective at each connection between the delivery device, the reservoir containing the biomaterial and the active ingredient that can be included, the mixer device, and the conduit that transports the biomaterial from the mixer device to the desired site. To provide a biomaterial delivery system with a unique seal. It will be appreciated that the mixer device may be provided with a cannula that has or does not have the mixing elements provided in the mixer device. Mixing of biomaterials can occur in mixing devices as well as in conduits. In one embodiment, the conduit comprises a mixing element, and in the same embodiment, the conduit comprises a cannula comprising the mixing element. The mixing element may be fixed at one end of the conduit, or preferably move along the length of the conduit (cannula or internal fracture fixation device). The movable mixing element may be movable in both directions along the length of the conduit. That is, the movable mixing element is adaptable to reciprocating motion along the length of the conduit. According to the present invention, configurations 2, 3 and 4 (shown in FIGS. 13, 14 and 15) are particularly advantageous and of the present invention in configurations 2, 3 and 4 of the system as described below. By using the system, the expiration date (shelf life) of the biomaterial can be significantly extended to several months or the like to the maximum.

The biomaterial delivery system, device, and method of the present invention can simply and effectively deliver the biomaterial to the site of interest and enhance fracture fixation without imposing any restraints on the user / surgeon. The systems, devices, and methods of the invention do not undergo a curing reaction (in a preferred embodiment, through the mixed tip of the mixer device of the system of the invention) until the injection is initiated, i.e. the curing reaction to the injection site. It has the advantage that it occurs during delivery and does not occur before delivery. In addition, there is a "start / stop" that the surgeon can resume delivery of biomaterials up to 2 hours after initial use by simply replacing the mixer device included in the delivery system of the present invention. You get the advantage and flexibility of being able. The delivery systems and devices of the present invention are suitable for delivering a wide variety of biomaterials and can be connected and particularly fitted with internal fracture fixation devices such as screws, nails, pins and the like. It is configured as follows. The internal fracture fixation device has a conduit that extends along the longitudinal axis of the internal fracture fixation device, the internal fracture fixation device fluidly communicates with the biomaterial reservoir, and the biomaterial moves the mixer device from the reservoir during use. As per, it may be configured to be delivered through the conduit of the internal fracture fixation device. In addition, the conduit is provided with an axial opening around the internal fracture fixing device so that the internal fracture fixing device is axially oriented and, if necessary, the internal fracture fixing device or the longitudinal axial direction. If it has a partially threaded configuration, it may be provided axially along the threaded ridge of the internal fracture fixation device.

The biomaterial delivery device of the present invention is a dispenser device, optionally, in a preferred embodiment, a dispenser device in the form of a dispenser gun, and a sealable reservoir of the biomaterial, optionally preferred embodiments. In the form of a sealable reservoir in the form of a cartridge having at least one sealable chamber, a mixer device and a conduit for transporting the biomaterial from the reservoir to the desired delivery site. In one embodiment, the conduit comprises a cannula. In another embodiment, the conduit comprises an internal fracture fixation device. Dispenser devices, optionally in the form of dispenser guns, are configured to expel biomaterials and active ingredients (if required) from the reservoir into the mixer device and conduit before being delivered to the injection site. There is. The advantage of the systems and devices of the present invention is that the systems and devices typically eject biomaterials from the entire device, minimizing the effort required for the user, typically a surgeon. While being able to be highly viscous, and typically to increase the mechanical forces required to successfully deliver a highly viscous biomaterial.

In one embodiment, the dispenser device is in the form of a dispenser gun, the reservoir comprises a cartridge, and the dispenser gun comprises a cartridge support for supporting a cartridge for accommodating a reservoir of biomaterial.

In one embodiment, the cartridge support may have a slot configured to fit into a cartridge containing a biomaterial. The delivery device may include an activation device that can be provided as an activation trigger capable of moving the plunger drive mechanism forward to expel the biomaterial from the reservoir / cartridge. Ideally, the first plunger is associated with the first chamber of the cartridge and the second plunger is associated with the second chamber of the cartridge. One or more plunger drive mechanisms may be associated with the first and second plungers. In a preferred embodiment, the activation mechanism is provided as a trigger mechanism that can be manually operated by the user. When the trigger is activated, the gripper plate fits into the plunger drive mechanism, the plunger drive mechanism advances the first plunger into the first chamber, and the second chamber is provided in the reservoir. May advance the second plunger into the second chamber, and the movement of the plunger or each plunger pushes the biomaterial out of the chamber of the cartridge or each chamber. The dispenser gun features an release button that allows the user / surgeon to manually pull the plunger if necessary to remove the cartridge. The cartridge unit typically has two or more chambers containing the biomaterial in the first chamber and the active ingredient (if required) or other biomaterial in the second chamber. Each chamber can contain the first biomaterial and other active ingredients separately until delivery to the surgical site is required.

In another embodiment, the cartridge unit may have three or more chambers depending on the formulation of the biomaterial. Each chamber of the reservoir cartridge comprises a generally cross-sectional tubular hermetically sealed housing that extends along the longitudinal axis, with the tube having a base end and a tip. The chambers or each chamber comprises a piston / plunger approximately located at the base end of the cartridge. The stopper member is located at the base end on the tubular wall of the cartridge to prevent the piston / plunger from being pushed out of the housing. By fixing a seal, such as a foil seal or stopper, or similar sealing means, to the base end of the cartridge to assist containment, the user / surgeon can remove this seal prior to use of the device. The tip of the cartridge provides a supply channel for fluid communication with the mixer. The number of channels will largely depend on the number of chambers included in the cylinder unit of a particular embodiment of the device of the invention so that each chamber can have its own channel for fluid communication with the mixer. The channels may be sealed with ultrasonic welding, foil seals, stopper caps, or similar sealing devices, respectively, to provide a suitable sealed seal before use. The surgeon can manually remove this seal from each channel in order to expose the contents of either channel prior to placing the mixer prior to delivery of the biomaterial. All components of the cartridge are manufactured using medical grade polymeric materials with excellent humidity / oxygen barrier properties inherent in the biomaterials contained therein.

In one embodiment, the mixer device comprises a generally tubular shaft having a proximal end and a distal end. The mixer device includes a mixer portion between the base end and the tip end of the mixer. At the proximal end, a specifically adapted connector allows the mixer to be attached to a cartridge with two or more chambers to assist delivery of the components to the mixing section of the mixer device. The interface between the cartridge and the mixer is designed to form a high quality seal that prevents loss / leakage of biomaterials and active ingredients. At the tip of the mixer, a luer lock allows the system to be connected to a cannula or other internal fracture fixation device such as a cannula mounting screw, nail, or pin. The mixing section typically comprises a mixing element, such as a spiral baffle or similar mixing element. The mixing element may be provided in multiple configurations capable of mixing and delivering biomaterials of different viscosities. The biomaterial is mixed by moving the mixer portion of the mixer device in which the biomaterial and the active ingredient are carried together. At this mixing step, the cure reaction begins, forming the required material at the exact location for dispensing, giving the surgeon complete control over the cure reaction. The system of the present invention provides mixer devices in a number of embodiments of the mixer device, each suitable for use with biomaterials of different viscosities. In one embodiment, the mixer device comprises a mixing element and, if desired, the mixer device can be located throughout approximately the entire length of the mixer shaft and may or may not be fixed to the proximal end of the mixer. The delivery system of the first embodiment of the present invention (the delivery system of the first embodiment is also referred to herein as configuration 1) is typically used for low viscosity biomaterials and delivery devices of this embodiment. , The components can be mixed up to 65500 times.

For highly viscous biomaterials, the mixer device may include a mixer shaft with a small number of mixed elements. Further, in another embodiment, the mixing element may not be fixed and may be freely movable along the entire length of the mixer shaft or substantially the entire length of the mixer shaft. The movement of the mixing element is possible in both directions, partially or entirely along the length of the mixer device. In yet another embodiment, the mixing element may be anchored to the proximal end of the mixer shaft (the delivery system of the second embodiment is also referred to herein as configuration 2). When the highly viscous biomaterial and active ingredient are dispensed into the mixer shaft containing the movable mixing element, it is pressurized against the mixing element at the tip, and the biomaterial and active ingredient are pressed before completing the mixing process. Have time to be partially mixed. This can reduce the viscosity of the components so that they can flow more freely through the mixing elements. By doing so, the note input can be significantly reduced, and thus the availability of the device can be increased.

In yet another embodiment, the third configuration of the present invention (the delivery system in the third embodiment is also referred to herein as configuration 3) has a mixer axis longer than the length of the mixer device of the previous embodiment. High viscosity activity with a large number of movable mixing elements in the mixing device to have, with the additional time to partially mix the biomaterial and active ingredient from the cartridge into the mixing shaft before reaching the mixing element at the tip. A delivery device for ingredients is provided. This allows the viscosity of the components to be further reduced and the mixing elements to flow freely. When a long mixing device is included in the system of the present invention, a shorter cannula than other embodiments of the present invention, such as a 50 mm cannula, can be used.

In yet another embodiment (the delivery system of the fourth embodiment is also referred to herein as configuration 4), for very viscous biomaterials, the mixer device comprises a mixer shaft without a mixing element. , In this embodiment, the mixing element is completely removed from the mixing axis. In this embodiment, the ingredients are in later stages, such as cannula devices and other internal fracture fixation devices such as cannula mounting screws including fenestration screws, nails, and pins that can be provided in the systems of the invention. Is mixed with. By removing all the mixing elements from the mixer, the biomaterial and the active ingredient can be partially but well mixed and their viscosity reduced before leaving the mixer. The cannula consists of a tubular tube with a base and tip, an inner diameter of 2.55 mm and an outer diameter of 3.5 mm (other diameters may be required depending on the biomaterial to be dispensed). At the proximal end, the cannula has a male luer lock that fits snugly into the female luer lock of the mixer. In addition, this end of the cannula has two wings that allow the surgeon to easily secure the cannula to the mixer. At the tip of the cannula, the last mixed biomaterial is dispensed from the complete device into the area of interest. The tip may have a rounded tip with a 1.5 mm opening or a flat tip with a 2.5 mm opening. A flat tip is typically used when the mixing element is contained in the mixer. If the mixing element is not in the mixer, the mixing element is typically placed in the cannula. The rounded tip cannula in this case prevents the mixing elements from moving out of the cannula housing when the biomaterial and active ingredient are dispensed. The purpose of moving the mixed element from the mixer to the tip of the cannula is to allow the biomaterial and the active ingredient to reach the element together over a longer period of time. This allows the components to be partially mixed to reduce the viscosity and thus allow them to flow more freely through the mixing elements. In terms of design, reducing the inner diameter from the mixer to the cannula can help the mixing process with the turbulence generated at this part. In addition, lower inner diameters increase the velocity of the components, which can reduce the overall pressure, as opposed to other systems described above. One of the main design features affecting the pressure gradient across the aforementioned system is the positioning of the mixing elements within the device. Early positioning within the device delays the reduction of component viscosity while creating a flow barrier before reaching the reduced inner diameter between the mixer and the cannula. This slows down the speed of the components in the system and thus increases the pressure. The working length of the cannula can be sized depending on the viscosity of the biomaterial and the requirements of the surgeon. Having a long working length cannula allows the biomaterial to mix with the active ingredient for a longer period of time before being dispensed into the area of interest. This also applies to all the systems mentioned above. In embodiments of systems that provide a longer cannula, such as where the mixer device has no mixing element and the cannula has a mixing element at the tip and is used in other embodiments of the invention, the viscosity of the components is cannulated. It is reduced along approximately the length and can increase the surgeon's injectability. The length of the mixer device can also be varied. In general, an embodiment of a system of the invention with a relatively long mixer device may have a relatively short cannula as compared to other embodiments of the invention. Thus, for example, it may be 50 mm, and in embodiments where the mixing element is short, it may have a long cannula, for example 100 mm. These variants are intended to maintain a consistent distance between the dispenser gun and the target area. This is also convenient for the surgeon as it mixes properly and keeps the hands at the optimum distance during the procedure.

The surgeon may optionally connect each mixer device of the embodiments of the invention described in configurations 1 to 4 above to a cannula to fill the bone space, or connect to any plurality of internal fracture fixation devices. And exacerbation of fixed trauma and orthopedic symptoms (ie, used without a cannula element). A detailed description of the overall functionality of the Cannula options has already been provided. For internal fracture fixation devices such as cannula mounting (opening) screws, pins, nails, or equivalents, connect to each mixer configuration by using a sheath or sheath adapter (with internal fracture fixation device). be able to. The tip of the sheath is provided with a standard thread that allows the surgeon to screw the sheath clockwise to secure it onto the internal fracture fixation device. A female luer lock is provided at the base end of the sheath so that the sheath can be connected to the sheath adapter. The tip of the sheath adapter is located inside the base end of the sheath. When the sheath adapter is fixed in place by screwing it clockwise, the tip of the device projects beyond the tip of the sheath into the cannula opening at the proximal end of the internal fracture fixation device. The base end of the sheath adapter is a male luer lock capable of connecting the entire device (sheath, sheath adapter, and internal fracture fixation device) to any of the mixers 1 through 4. In the mixers of configurations 1 to 3, mixing of the biomaterial with the active ingredient is completed before entering the sheath adapter and the internal fracture fixation device. For the mixer of configuration 4, the mixing of the biomaterial and the active ingredient is complete upon entry into the internal fracture fixation device. In this design, a complete mixing process occurs further within the system as the components pass through the various shapes of the sheath adapter and the cannula-mounted internal fracture fixation device. These shapes generate sufficient turbulence to evenly mix the components to provide the required cure time and compressive strength properties.

First, the sheath is secured to the internal fracture fixation device by screwing the sheath clockwise. Place the tip of the sheath adapter inside the sheath from the upper end.

The four parts can be quickly assembled in the operating room at any time before the system is used. Since the biomaterial fracture fixation system is a "point and chute" setting, the mixer is installed in one step, a cannula is attached if necessary, and the trigger is pulled on the dispenser gun to simply deliver to the target site. The system can also have a "stop-start" function. When the injection is stopped, the injection can be resumed within a short time (about 30 seconds) without changing the mixer, or up to 2 hours after removing the used mixer and replacing it with a new one.

The system can deliver any required biomaterial as long as it is formulated to flow through the mixer and cannula system. The dispenser gun provides the surgeon with the significant mechanical advantage of being able to apply 5.5 times as much force to the cartridge as the surgeon exerts on the dispenser gun. This also allows the surgeon to inject biomaterials that are not possible using conventional systems.

The present application will be described with reference to many alternative embodiments shown in the accompanying drawings for purposes of illustration only.

FIG. 1 is a perspective view of a dispenser device in the form of a dispenser gun according to an embodiment of the present invention. FIG. 2 is a side view of the dispenser device of FIG. FIG. 3 is a top view of the dispenser device of FIG. FIG. 4 is a perspective view of a reservoir containing a biomaterial in a hermetically sealed manner according to an embodiment of the present invention, and the reservoir includes a cartridge having the characteristics shown in FIG. 5 (a) is a longitudinal sectional view of the cartridge shown in FIG. 4, FIG. 5 (b) is a view showing a base end of the cartridge, and FIG. 5 (c) is a mixer while the cartridge is in use. FIG. 5 is a longitudinal sectional view of the base end of a cartridge showing a supply channel configured to communicate fluid with a mixer device when connected to a device. FIG. 6 (a) is a rear view of a cartridge cap for sealing the base end of the cartridge on the opposite side of the supply channel provided at the tip of the cartridge during use, and FIG. 6 (b) is a rear view of FIG. 6 (a). ) Is a side view of the cartridge cap, and FIG. 6 (c) is a side view of the cartridge cap rotated. FIG. 7 (a) is a perspective view of an embodiment of a piston according to the present invention capable of ejecting a biomaterial and any active ingredient (if necessary) from a chamber of a cartridge or each chamber. (B) is a side view of the piston, and FIG. 7 (c) is a cross-sectional view of the piston of FIG. 7 (a). 8 (a) is a perspective view of a piston according to another embodiment of the present invention, FIG. 8 (b) is a side view of the piston of FIG. 8 (a), and FIG. 8 (c) is a view. It is sectional drawing of the piston of 8 (a). 9 (a) is a front view of the first embodiment of the mixer device according to the present invention, and FIG. 9 (b) is a sectional view of the mixer device of FIG. 9 (a) in the longitudinal direction. 10 (a) is a side view of the cannula connected to the mixer devices of FIGS. 9 (a) and 9 (b), and FIG. 10 (b) is a longitudinal sectional view of the cannula of FIG. 10 (a). Is. FIG. 11A is a side view of a cannula-mounted fracture fixing in which the thread is partially provided in the present embodiment and the ridgeline of the screw thread extends only partially along the length direction of the fracture fixing device. 11 (b) shows a threaded embodiment of another embodiment of cannulated fracture fixation in which the ridge of the thread extends along approximately the entire length of the fracture fixation device. It is a side view, FIG. 11 (c) is a side view of the sheath fitted to the fracture fixing device according to the present invention, and FIG. 11 (d) is housed in the sheath of FIG. 11 (c) according to the present invention. 11 (e) is a side view of the sheath adapter partially inserted into the sheath, and FIG. 11 (f) is a side view of the sheath adapter partially inserted into the sheath. The figure shows a state in which the sheath is completely inserted into the sheath until the tip of the sheath adapter protrudes beyond the tip of the sheath, and the sheath having a thread arranged on the inner surface of the tip is configured to fit into the fracture fixing device. It is a figure which shows. FIG. 12 is a schematic diagram of a first configuration of a system of the invention comprising the mixer device of FIG. 9, the sheath of FIG. 11c, the sheath adapter, the cannula, and the internal fracture fixation device according to the invention. .. FIG. 13 is a schematic representation of a second configuration of a system of the present invention comprising a mixer, a sheath, a sheath adapter, a cannula, and an internal fracture fixation device according to the present invention. FIG. 14 is a schematic representation of a third configuration of a system of the invention according to the invention, comprising a mixer, a sheath, a sheath adapter, a cannula, and an internal fracture fixation device. FIG. 15 is a schematic view of a fourth configuration of a mixer, a sheath, a sheath adapter, a cannula, and an internal fracture fixation device according to the present invention. FIG. 16 is a perspective view of a fully assembled embodiment of the present invention. FIG. 17 is a perspective view of another embodiment of the present invention. FIG. 18 (a) is a schematic view of another embodiment of the present invention having three biomaterial components, and FIG. 18 (b) is a longitudinal sectional view of another embodiment of a cartridge having three cylinders. FIG. 18 (c) is a top view of another embodiment of a dispenser gun having three biomaterial components. FIG. 19 is a bar graph showing a comparison of note inputs in the system of the first configuration (configuration 1) using a new biomaterial (0 days old) and an expired biomaterial (+4 months old). Comparison of systems in configuration 1 and 4 using only expired biomaterials (+4 months old).

Description of the Invention with Reference to the Drawings The present invention will be described with reference to the accompanying drawings. Each part of the delivery device of the present invention is shown with reference to the following reference numerals. Similar parts are indicated by similar reference numbers.

1 to 3 are views showing different perspective views of the dispenser gun 100 according to the embodiment of the present invention. The dispenser gun 100 includes an adjustment slot 102 that supports a cartridge (not shown) containing a biomaterial, and the housing 101 of the system rotatably supports the activation trigger 103 to advance the plunger drive mechanism. When the trigger 103 is activated by pulling the fixed handle 104 toward you, the gripper plate is fitted to the drive mechanism to advance the plungers 105 and 106. The drive mechanism includes gripper plate teeth 107 to prevent the plungers 105 and 106 from returning. The dispenser gun includes a release button 108 that allows the surgeon to manually pull the plungers 105, 106 if necessary to remove the cartridge (not shown).

The gripper plate guides 111 and 112 extend vertically from the top of the plungers 105 and 106, respectively.

A second slot 109 is further provided at the rear of the plungers 105 and 106. The second slot 109 has a function of helping to manually pull back the gripper plate.

FIG. 4 is a perspective view of the cartridge of one embodiment, and is represented by reference numeral 200 as a whole. FIG. 5 is a view of a cartridge shown in its entirety by reference numeral 200 according to one embodiment, and FIG. 5 shows (a) a sectional view in a longitudinal direction, (b) a front view, and (c) a tip portion, respectively. It is a cross-sectional view of.

The cartridge 200 comprises two chambers 201, 202 that separately house the biomaterial and the active ingredient until required at the surgical site. Other chambers (not shown) may be added by formulation of biomaterial. Each chamber comprises a cylinder with a longitudinal axis having a proximal end 203 and a distal end 204. All cylinders include a piston / plunger (detailed in FIGS. 7 and 8) located approximately at the base of the cartridge. The stopper member 205 is located at the base end of the cylindrical wall of the cartridge to prevent the piston / plunger from being pushed out of the housing. A foil seal, stopper 207, or equivalent supports the container and is secured to the base end 203 of the cartridge, which the surgeon can remove prior to use of the device. The base end further comprises a base configured to be secured to the dispenser gun 100. The tip 204 of the cartridge includes a supply channel 209 to the mixer. These supply channels may be covered by a cap 215 (shown in FIG. 6), which is held in place by the fixing member 211. The number of channels 209 is dominated by the number of chambers 201, 202 used. The channels may be sealed with ultrasonic welding, foil seals, stopper caps, or equivalents, respectively, to provide a sealed seal before use. The surgeon can manually remove the seal from the channel to expose the contents prior to placement of the mixer 300 (shown in FIG. 6). All components of the cartridge are manufactured using medical grade polymeric materials with excellent humidity / oxygen barrier properties.

FIG. 6 includes a cartridge cap 215 that includes a seal 217 for the channel at the tip 204 of the cartridge 200 and a guide notch 219 for ensuring and accurate placement of the cap on the cartridge. The cap also has a handle 221 that assists in removing the cap.

FIG. 7 shows a piston 230 for the cartridge of the present invention. The piston comprises a substantially tubular piston housing 231 surrounded by an O-ring (233). The piston has a tapered base end 235 and a flat tip 237. In addition, the piston has a collar 239 at its base end that extends outward and acts as a seal.

FIG. 8 shows another embodiment of the piston 250 according to the present invention. The piston 250 differs from the piston 230 mainly in that it is larger in height than its diameter. The diameter of the piston 230 is greater than the distance from the proximal end to the distal end. Due to this difference, the required internal structure differs, and the relatively wide piston 230 has a relatively large empty space inside. This configuration is particularly good at preventing the ingress of water, which can damage the contents of the cartridge.

FIG. 9 shows a first embodiment of an embodiment of the mixer 300 according to the present invention.

The mixer 300 includes a tubular shaft having a base end 301 and a tip end 302. At the proximal end 301, a specially suited connector allows the mixer to be attached to a cartridge 200 having two or more chambers and assisting in delivering the components to the mixing section via the inlet channel 311. Become. The interface between the cartridge and the mixer has a guide notch 313 to ensure a correct connection so that a high quality seal can be formed and the loss / leakage of biomaterial or active ingredient can be prevented. It is designed. At the tip of the mixer, the Luer Lock 305 allows the system to be connected to a cannula or other internal fracture fixation device such as a cannula mounting screw, nail, or pin. Between the base end 301 and the tip end 302 of the mixer is a mixing portion. This portion typically comprises a spiral baffle or similar mixing element, which can be provided in multiple configurations to handle biomaterials of different viscosities. The biomaterial is mixed by moving the mixing shaft 307 in which the biomaterial and the active ingredient are carried together. At this stage, the curing reaction begins and forms the required material at the exact location for dispensing, giving the user or surgeon complete control over the curing reaction. The mixing element may be located over the entire length of the mixer shaft and may or may not be fixed to the proximal end of the mixer. This configuration (Structure 1) is typically used for biomaterials low in clay and can mix the components up to 65500 times. For highly viscous biomaterials, the mixer shaft may contain a smaller number of mixed elements. The mixing element may be movable or fixed in place within the mixing axis.

FIG. 10 is a diagram showing an embodiment of the cannula 500 according to the embodiment of the present invention. The cannula has both a proximal 501 and a distal end 502 and comprises a tubular tube with an inner diameter of 2.55 mm and an outer diameter of 3.5 mm. At the proximal end, the cannula has a male luer lock 503 that can be secured to the female luer lock of the mixer. In addition, this end of the cannula has two wings 505 that allow the user or surgeon to easily secure the cannula to the mixer. At the tip of the cannula, the last mixed biomaterial is dispensed from the complete device into the area of interest. The tip may be a rounded tip with an opening of 1.5 mm, or a flat tip with an opening of 2.5 mm (diameter may vary depending on the biomaterial to be dispensed) (shown in FIG. 10a). ) May have. A flat tip is typically used when the mixing element is contained in the mixer. If the mixing element is not in the mixer, the mixing element is typically placed in the cannula. A rounded tip cannula is used in this case to prevent the mixing elements from being pushed out of the cannula housing when the biomaterial and active ingredient are dispensed. The purpose of moving the mixed element from the mixer to the tip of the cannula is to allow the biomaterial and the active ingredient to reach the element together over a longer period of time. This allows the components to be partially mixed to reduce the viscosity and thus allow them to flow more freely through the mixing elements. In terms of design, reducing the inner diameter from the mixer to the cannula can help the partial mixing process with the turbulence generated at this portion. In addition, lower inner diameters increase the velocity of the components, which can reduce the overall pressure, as opposed to other systems described above. A tapered needle tip, a chamfered needle tip, or another needle tip shape may be used.

One of the main design features that generate pressure within the aforementioned system is the positioning of the mixing elements. Positioning early in the process limits the reduction in component viscosity while creating a flow barrier before reaching the reduced inner diameter between the mixer and the cannula. This slows down the speed of the components in the system and thus increases the pressure. The working length of the cannula can be sized depending on the viscosity of the biomaterial and the requirements of the surgeon. Having a long working length cannula allows the biomaterial to mix with the active ingredient for a longer period of time before being dispensed into the area of interest. This also applies to all the systems mentioned above. In a system where the mixer does not have a mixing element and the cannula has a mixing element at the tip, a longer cannula can substantially reduce the viscosity of the components, thus increasing the surgeon's injectability.

FIG. 11 shows various internal fracture fixing devices, in this case cannula mounting screws 510 and 530 that can be coupled to any mixer of the present invention by using a sheath 550 (with an internal fracture fixing device) and a sheath adapter 551. There is. The screws 510 and 530 may have a cannula inserted and may have an open window 515, through which the biomaterial passes when the screws 510 and 550 are placed in place in the bone. The biomaterial that passes through the fenestration of the screw acts as an adhesive between the screw and the bone. This secures the screw even more firmly than the result of fixing the screw in place in the bone with its thread alone. This just means that you don't have to thread the entire screw to secure it. The tip of the screw may have a thread and the middle or base may be smooth, and having an fenestration along the entire length allows the biomaterial to exit the fenestration and run between the bone and the screw along the entire length of the screw. To form a seal. This is advantageous because the action of drilling into the bone is undesirable because the surrounding bone can be finely chipped. The location of the fenestration also allows the passage of screws of more viscous biomaterials than would otherwise be possible. The tip 554 of the sheath adapter is provided with a standard thread 553 (not shown) that allows the surgeon to screw the sheath adapter clockwise to secure it onto the internal fracture fixation device. Complementary threads 513 and 533 are provided on the cannula mounting screws 510 and 530. A female luer lock 552 that can connect the sheath to the sheath adapter is provided at the base end of the sheath. The tip of the sheath adapter 554 is located inside the base end of the sheath. When the sheath adapter is fixed in place by screwing clockwise, the tip of the device projects beyond the tip of the sheath 555 into the cannula opening at the proximal end of the internal fracture fixation device. The base end of the sheath adapter is a male capable of connecting the entire device (sheath 550, sheath adapter 551, and internal fracture fixing device 510, 530) to any of the mixers of configurations 1 to 4 as shown in FIGS. 12 to 15. A lure lock 556 is provided.

Figures 12-15 use cannula configurations 1-4, respectively, to fill the bone voids, or multiple internal fracture fixation devices (ie, without cannula components) for exacerbation of signs of fixation trauma. Is shown. In the mixers 300, 310, 320 of configurations 1 to 3, mixing of the active ingredient of the biomaterial is completed prior to entering the sheath adapter and the internal fracture fixation device.

FIG. 12 shows a first configuration of an assembly of a mixer 300, a cannula 500, a sheath 550, a sheath adapter 551, and a screw 530 according to the present invention. The mixing element 309 is fixed to the base end of the mixer and extends to the full length of the mixing shaft 307. This arrangement (Structure 1) is typically used for low viscosity biomaterials, and the delivery device of this embodiment can mix the components up to 65500 times due to the large number of mixing elements.

FIG. 13 shows a second configuration of an assembly of mixer 310, cannula 500, sheath 550, and screw 530 according to the present invention. A small number of mixing elements 309 are movable along the entire length of the mixing shaft 307. This configuration is typically used for high viscosity biomaterials. Further, in another embodiment, the mixing element may not be fixed and may be freely movable along the entire length of the mixer shaft or substantially the entire length of the mixer shaft. In yet another embodiment, the mixing element may be fixed to the proximal end of the mixer shaft. When the highly viscous biomaterial and active ingredient are dispensed into the mixer shaft 307 containing the mobile mixing element, it is pressurized against the mixing element at the tip and is active with the biomaterial before completing the mixing step There is time for the ingredients to be partially mixed. This allows the viscosity of the components to be reduced so that they can flow more freely through the mixing element 309. By doing so, the note input can be significantly reduced, and thus the availability of the device can be increased.

FIG. 14 shows a third configuration with another mixer 320. This configuration is a delivery device for high viscosity biomaterials with an extended mixer shaft 307 with a small number of movable mixing elements 309. As the components enter the mixing shaft 307 from the cartridge 200, the time to partially mix before reaching the tip mixing element 309 is further extended. This allows the viscosity of the components to be further reduced and the mixing elements to flow freely.

FIG. 15 shows a fourth configuration in which the mixing shaft has no mixing element. This is particularly suitable for high viscosity biomaterials. At the time of dispensing, there are enough mixing elements 309 at the tip of the cannula to produce a uniform mixture.

For the mixer 330 of configuration 4, the mixing of the biomaterial and the active ingredient is complete upon entry into the internal fracture fixation device. In this design, the complete mixing process is further within the system by allowing the components to pass through the various shapes of the sheath adapter and the cannula-mounted internal fracture fixation device. These shapes generate sufficient turbulence to evenly mix the components to provide the required cure time and compressive strength properties.
In this embodiment, the components are mixed at a later stage, such as the cannula device 500 and other internal fracture fixation devices such as cannula mounting screws, nails, and pins. By removing all the mixing elements from the mixer, the biomaterial and the active ingredient can be partially but well mixed and their viscosity reduced before leaving the mixer. The cannula consists of a tubular tube with a base and tip, an inner diameter of 2.55 mm and an outer diameter of 3.5 mm (otherwise specified by the biomaterial used). At the proximal end, the cannula has a male luer lock that fits snugly into the female luer lock of the mixer. In addition, this end of the cannula has two wings that allow the surgeon to easily secure the cannula to the mixer. At the tip of the cannula, the last mixed biomaterial is dispensed from the complete device into the area of interest. The tip may have a rounded tip with a 1.5 mm opening or a flat tip with a 2.5 mm opening (otherwise specified by the biomaterial used). A flat tip is typically used when the mixing element is contained in the mixer. If the mixing element is not in the mixer, the mixing element is typically placed in the cannula. The rounded tip cannula in this case prevents the mixing elements from moving out of the cannula housing when the biomaterial and active ingredient are dispensed. The purpose of moving the mixing element 309 from the mixer to the tip of the cannula is to allow the biomaterial and the active ingredient to reach the element together over a longer period of time. This allows the components to be partially mixed to reduce the viscosity and thus allow them to flow more freely through the mixing elements. In terms of design, reducing the inner diameter from the mixer to the cannula can help the partial mixing process with the turbulence generated at this portion. In addition, lower inner diameters increase the velocity of the components, which can reduce the overall pressure, as opposed to other systems described above. One of the main design features that generate pressure within the aforementioned system is the positioning of the mixing elements. Positioning early in the process limits the reduction in component viscosity while creating a flow barrier before reaching the reduced inner diameter between the mixer and the cannula. This slows down the speed of the components in the system and thus increases the pressure. The working length of the cannula can be sized depending on the viscosity of the biomaterial and the requirements of the surgeon. Having a long working length cannula allows the biomaterial to mix with the active ingredient for a longer period of time before being dispensed into the area of interest. This also applies to all the systems mentioned above. In a system where the mixer does not have a mixing element and the cannula has a mixing element at the tip, a longer cannula can substantially reduce the viscosity of the components, thus increasing the surgeon's injectability.

The surgeon connects the mixers of configurations 1-4 to a cannula to fill the bone voids or to multiple internal fracture fixation devices for exacerbation of signs of fixation trauma (ie, used without cannula parts). Have choices. A detailed description of the overall functionality of the Cannula options has already been provided. For internal fracture fixation devices such as screws, pins, nails, or equivalents, sheaths or sheath adapters (provided with internal fracture fixation devices) can be used to connect to each mixer configuration. The tip of the sheath is provided with a standard thread that allows the surgeon to screw the sheath clockwise to secure it onto the internal fracture fixation device. A female luer lock is provided at the base end of the sheath so that the sheath can be connected to the sheath adapter. The tip of the sheath adapter is located inside the base end of the sheath. When the sheath adapter is fixed in place by screwing it clockwise, the tip of the device projects beyond the tip of the sheath into the cannula opening at the proximal end of the internal fracture fixation device. The base end of the sheath adapter is a male luer lock capable of connecting the entire device (sheath, sheath adapter, and internal fracture fixation device) to any of the mixers 1 through 4. In the mixers of configurations 1 to 3, mixing of the biomaterial with the active ingredient is completed before entering the sheath adapter and the internal fracture fixation device. For the mixer of configuration 4, the mixing of the biomaterial and the active ingredient is complete upon entry into the internal fracture fixation device. In this design, the complete mixing process is further within the system by allowing the components to pass through the various shapes of the sheath adapter and the cannula-mounted internal fracture fixation device. These shapes generate sufficient turbulence to evenly mix the components to provide the required cure time and compressive strength properties.

A fully assembled configuration with a cannula is shown in FIG.

When in use, the cannula 500 is secured to the mixer 300 by the luer lock 305.

Parts can be quickly assembled in the operating room at any time before using the system. Since the biomaterial fracture fixation system is a "point and chute" setting, simply attach the mixer and cannula and pull the trigger of the dispenser gun to deliver to the target site. The system can also have a "stop-start" function. When the injection is stopped, the injection can be resumed within a short time without changing the mixer, or up to 2 hours after removing the used mixer and replacing it with a new one.

The system can deliver any required biomaterial as long as it is formulated to flow through the mixer and cannula system. The dispenser gun 100 provides the surgeon with the significant mechanical advantage of being able to apply 5.5 times the force the surgeon exerts on the dispenser gun 100 on the cartridge. This also allows the surgeon to inject biomaterials that are not possible using conventional systems.

FIG. 17 is another assembled delivery system.

At the time of use, the base end of the screw 510 is fixed to the tip of the sheath adapter 551. The base end of the sheath adapter 551 is connected to the tip of the mixer 300 with a luer lock 305.

The four parts can be quickly assembled in the operating room at any time before the system is used. Since the biomaterial fracture fixation system is a "point and chute" setting, the mixer is installed in one step, a cannula is attached if necessary, and the trigger is pulled on the dispenser gun to simply deliver to the target site. The system can also have a "stop-start" function. When the injection is stopped, the injection can be resumed within a short time (30 seconds) without changing the mixer, or up to 2 hours after removing the used mixer and replacing it with a new one.

The system can deliver any required biomaterial as long as it is formulated to flow through the mixer and cannula system. The dispenser gun provides the surgeon with the significant mechanical advantage of being able to apply 5.5 times as much force to the cartridge as the surgeon exerts on the dispenser gun. This also allows the surgeon to inject biomaterials that are not possible using conventional systems.

This system includes a fenestration screw 510. Once the screw is placed in place on the bone as an internal fixation device, the biomaterial can pass through the screw hole or fenestration 515 and exit from the tip. This results in stronger adhesion between the bone and the screw than with the bone and the screw alone. By positioning the fenestration, even highly viscous biomaterials can be screwed through to the tip.

A method of delivering a biomaterial to a desired site according to the present invention will be described.

A method of delivering a biomaterial to a desired site using a biomaterial delivery system comprises the following steps.
The biomaterial delivery system is assembled by performing the following steps.
1. 1. Attach the cartridge (having two or more chambers) to the dispenser gun.
2. 2. Attach the mixer to the cartridge (using a lure or similar lock attachment).
3. 3. Attach a cannula or internal fracture fixation device (screws, nails, and pins) to the mixer.

Following this assembly, the cement can be delivered by activating the device, typically the actuator is equipped with a hand-operated actuator trigger, typically pulling the trigger to activate the delivery device. The biomaterial and active ingredient pass through the mixer and cannula (if necessary) to initiate the curing reaction.

All embodiments / configurations of the mixing system allow the components to be mixed several times prior to delivery to the site of interest to meet the desired performance criteria.

The dispenser gun of the present invention is designed to facilitate positioning of the cartridge without undue force or difficulty on the part of the surgeon. When using a dispenser gun, the force experienced by the surgeon is one-5.5th of the force exerted on the cartridge. The average force required to inject cement in the mixing system of configuration 1 (the most force-requiring design) is about 400 N, which is reduced to 72.7 N applied by the dispenser gun operator. This is clearly below the power calculated to be achievable by more than 95% of women, according to ergonomic standards (ANSI American National Standards Institute / AAMI HE75, 2009).

Testing on this system revealed the following:
The cartridge-mixer seal can withstand forces up to 800N until a leak occurs.
-The cartridge can withstand an internal force of 1200 N before it breaks.
• After the first injection through the mixer / cannula, the injection can be resumed for up to 30 seconds without changing the mixer / cannula.
• For several hours after the first injection, the injection can be resumed by removing the mixer / cannula and placing a new one in the cartridge.
-By formulation, for biomaterials that cannot be injected by the system of configuration 1 (exceeding the threshold of 700N), the biomaterial can be easily injected through the system of configuration 4 (average injection input 270N). See FIG.
The expiration date (shelf life) of the biomaterial can be maximized by using the systems of configurations 2, 3, and 4. In particular, one of the factors that determines the expiration date of the biomaterial is the time required for the injection input to exceed the threshold value of 700N.
-Whether the biomaterial and the active ingredient are perfectly mixed can be determined by wet field curing penetration. The results of configurations 1, 2, and 4 show that the value of 8 MPa (the value specified for the tested biomaterial) can reach the threshold within 10 minutes using the same biomaterial with different material ages. did it.
-The biomaterial used in the above test had a shelf life of 3 months delivered in configuration 1. In configuration 1, a biomaterial having a long shelf life of 4 months cannot be dispensed because the material having a high viscosity already becomes more viscous with the passage of time. Configurations 2 and 4 facilitate the dispensing of expired biomaterials, which is a uniform mixture that achieves the essential properties of injection, compressive strength, and wet field curing penetration tolerance criteria, respectively. (Biomaterials and active ingredients) can be provided.
FIG. 19 is a diagram showing a comparison in which the injection of the system of configuration 1 was performed with a new biomaterial (0 day old) and an expired biomaterial (+4 months old). Comparison of systems in configuration 1 and 4 using only expired biomaterials (+4 months old).
Table 1 shows that all configurations tested for wet field curing penetration achieved a value of 8 MPa within a 10 minute threshold using the same biomaterial over time.

As an alternative to the cannula, a mixer (any configuration) can be connected to any internal fracture fixation hardware with luer (or similar) connections (eg, cannula mounting screws, nails, or pins). This allows the surgeon to easily use this system in association with any compatible system to enhance the effectiveness of both.

This system is not limited to delivering one type of biomaterial. Any biomaterial formulated for delivery via the mixer and cannula may be compatible with the delivery systems and devices of the invention. The systems and devices of the present invention will also allow surgeons to deliver multiple types of biomaterial within a single operation. Cartridges containing the required biomaterial are loaded into the dispenser gun as needed and delivered as needed during surgery to enhance fracture fixation. For example, this allows the surgeon to bond high-strength low-speed modified cement where stability is important, high-strength load-bearing support when fixation is required, or fracture reduction and placement when importance is important. The agent can be delivered.

The advantages of the system, device, and method of the present invention are as follows.
1. 1. A biomaterial fracture fixation enhancer is a system associated with a "point and shoot" medical device that is easy to assemble and allows surgeons to deliver biomaterials or multiple types of biomaterials during orthopedic and trauma surgery. Can be controlled.
2. 2. The biomaterial fracture fixation enhancement device enables a "stop start" method of delivery. The biomaterial begins to cure only when the trigger of the device is pressed and the biomaterial is delivered to the mixer and the clinical site of interest. After a portion of the material has been delivered, injection can be resumed in a short time frame (eg, 30 seconds) without changing the mixer, and up to 2 hours after replacing the old mixer with a new one.
3. 3. The system can deliver any biomaterial compatible with it, i.e. any biomaterial that is formulated to flow through a mixer and / or cannula.
4. The system provides the ability to connect to internal fracture fixation hardware and further enhances fracture fixation.

FIG. 18 (a) schematically illustrates a plurality of delivery supplies for supplying a delivery system according to another embodiment of the invention, as exemplified by the three chambers of the biomaterial reservoir.

18 (b) and 18 (c) are cross-sectional views showing in more detail another embodiment of FIG. 18 (a), in which the plurality of reservoirs exceeds two in the cartridge 250. Provided in the form of a number of chambers, for example, three chambers 201, 202, 251 are provided on the cartridge 250 as shown in FIGS. 18 (b) and 18 (c), eg, any number of chambers in the cartridge. Of course, the delivery system may be provided with a supply of any number of reservoirs of biomaterial.
FIG. 19 is a bar graph showing a comparison of the input of the system of configuration 1 with a new biomaterial (0 days old) and an expired biomaterial (+4 months old). Comparison of systems in configuration 1 and 4 using only expired biomaterials (+4 months old).

In summary, the systems, devices, and methods of the present invention have the following advantageous features:
1. 1. The dispenser device, the dispenser device, comprising an actuator that can be operated to dispense the biomaterial to a desired site of interest and activate the delivery device, and is configured to fit into a reservoir containing the biomaterial. With a mixer device for mixing any activator that may be needed,
A biomaterial delivery system comprising a conduit for transporting the biomaterial from the mixer device to the desired site of interest.
2. 2. The biomaterial delivery system according to description 1, wherein the conduit comprises a cannula or a cannula-mounted fracture fixation device.
3. 3. The dispenser device according to description 1 or 2 comprising an operable means for discharging the biomaterial and any active ingredient from the reservoir into the mixer device and the conduit for delivery to the desired site of interest. Biomaterial delivery system.
4. The biomaterial delivery system according to any one of the above description numbers, wherein the dispenser device comprises a reservoir containing the biomaterial.
5. The biomaterial delivery system according to any one of the above description numbers, wherein the reservoir comprises a cartridge containing the biomaterial.
6. The biomaterial delivery system according to any one of the description numbers, wherein the delivery device fits into the reservoir and comprises a reservoir locking means that holds the reservoir in place on the delivery device.
7. The biomaterial delivery system according to description 6, wherein the locking means comprises a slot configured to fit into the cartridge.
8. The delivery device comprises any of the description numbers comprising a delivery gun and a housing of the delivery gun that rotatably supports an activation trigger that is operable to advance the plunger drive mechanism to release the biomaterial from the cartridge. The biomaterial delivery system according to one.
9. The biomaterial delivery device according to description 8, wherein when the trigger is activated, the gripper plate is fitted into the drive mechanism, and the drive mechanism advances the plunger.
10. The biomaterial delivery system according to any one of the above description numbers, wherein the dispenser gun comprises a release button that allows the user to manually retract the plunger if necessary to remove the cartridge.
11. The reservoir comprises a cartridge unit with a first chamber containing the biomaterial, and optionally separate from each other until the cartridge requires the biomaterial and the second material at the surgical site. The biomaterial delivery system according to any one of the above description numbers, comprising a second chamber for accommodating the second material to be accommodated.
12. The biomaterial delivery system according to description 11, wherein the cartridge comprises two or more chambers containing the biomaterial and the active ingredient separately from each other until required at the site of the surgery.
13. The biomaterial delivery system according to description 11, wherein the cartridge unit has three or more chambers depending on the formulation of the biomaterial.
14. The biomaterial according to any one of descriptions 11-14, wherein each chamber has a generally elongated longitudinal axis in the form of a tubular cross section, the cylinder, or each cylinder having a proximal end and a distal end. Delivery system.
15. The biomaterial delivery system according to any one of descriptions 11 to 15, wherein the cylinder or each cylinder optionally comprises a piston located approximately at the proximal end of the cartridge.
16. The biomaterial delivery system according to description 15, wherein the stopper member is located at the base end on the tubular wall of the cartridge to prevent the piston / plunger from being pushed out of the housing.
17. The biomaterial delivery system according to description 11-17, wherein a sealing means is provided at the base end of the cartridge to assist in sealing, and the surgeon can remove the seal prior to use of the device.
18. The biomaterial delivery system according to any one of the above descriptions, wherein the tip of the cartridge comprises a supply channel for fluid communication with the mixer.
19. The biomaterial delivery according to description 18, wherein the number of channels corresponds to the number of chambers included in the cylinder unit of the particular embodiment of the device, so that each chamber has its own channel for fluid communication with the mixer. system.
20. Each of the channels preferably comprises one or more removable sealing means selected from ultrasonic welding, foil sealing, stopper caps, or similar sealing devices, by providing a sealing enclosure prior to use. The biomaterial delivery according to the description, wherein the seal is configured to allow the biomaterial to be removed from each of the channels to expose the contents of any channel prior to placing the mixer at the desired delivery site. system.
21. The biomaterial delivery system according to one of the above descriptions, wherein all components of the cartridge are manufactured using a medical grade polymeric material having the humidity / oxygen barrier properties required by the formulation of the biomaterial to be delivered. ..
22. The biomaterial delivery system according to any one of the above description numbers, wherein the mixer device comprises a tubular shaft having a proximal end and a distal end. The mixer device may be provided with a mixing element. Alternatively, the mixer device may not be provided with a mixing element, and instead, in this embodiment, the mixing element may be provided in a conduit that delivers the biomaterial to the desired delivery site. The conduit that transports the biomaterial from the mixer device to the desired delivery site includes a cannula or internal fracture fixation device, which has a connector at the proximal end and can be hermetically fitted to the mixer device.
23. 22. The biomaterial delivery system of description 22, wherein the mixer device fits into the reservoir of biomaterial at one end and a conduit for delivering the biomaterial to a desired delivery site at the other end.
24. At the proximal end of the mixer device, the mixer device is optionally fitted with the reservoir in the form of a cartridge to connect the mixer to the reservoir and to the mixing portion of the mixer. 23. The biomaterial delivery system according to description 23, comprising a connector configured to assist delivery of the component.
25. 23. The biomaterial delivery system according to description 23, wherein the interface between the cartridge and the mixer is designed to provide a high quality seal that prevents loss / leakage of the biomaterial or active ingredient.
26. Description 25, wherein a locking means is provided at the tip of the mixer so that the delivery system can be connected to a cannula or other internal fracture fixation device such as a cannula mounting screw, nail, or pin. The biomaterial delivery system described.
27. The biomaterial delivery system according to description 25, wherein the mixer device comprises a mixing portion between the proximal end and the distal end of the mixer device.
28. The biomaterial delivery system according to description 27, wherein the mixing unit comprises a mixing element configured to allow mixing of biomaterials of different viscosities.
29. The biomaterial delivery system according to description 28, wherein the mixed element comprises a spiral baffle or a similar mixed element.
30. A biomaterial delivery system in which the expiration date (shelf life) of a biomaterial is maximized using configurations 2, 3, and 4 of the system described herein.
31. The biomaterial is mixed by moving the material along the mixer device, and the movement is the material through a mixing shaft that can be provided in the mixer device of one embodiment that transports the biomaterial and the active ingredient together. A delivery system according to the invention, comprising moving the device. At this stage, the cure (curing) reaction begins, forming the required material at the exact location for dispensing, giving the surgeon complete control over the curing reaction.
In one embodiment, the mixing element may or may not be located approximately the entire length of the mixer shaft and may or may not be fixed to the proximal end of the mixer. This arrangement (Structure 1) is typically used for low viscosity biomaterials, and the delivery device of this embodiment can mix the components up to 65500 times.
32. For high viscosity biomaterials, the mixer shaft is a biomaterial delivery system that may contain a small number of mixed elements. In another embodiment, the mixing element is not fixed and may move freely, preferably in both longitudinal directions, along the overall length of the mixer shaft or approximately the length of the mixer shaft. In yet another embodiment, the mixing element may be fixed to the proximal end of the mixer shaft (Structure 2). When the highly viscous biomaterial and active ingredient are dispensed into the mixer shaft containing the movable mixing element, it is pressurized against the mixing element at the tip, and the biomaterial and active ingredient are pressed before completing the mixing process. Have time to be partially mixed. This can reduce the viscosity of the components so that they can flow more freely through the mixing elements. By doing so, the note input can be significantly reduced, and thus the availability of the device can be increased.
33. A delivery device for high viscosity biomaterials with a small number of movable mixing elements on an extended mixer shaft. As the components enter the mixing shaft from the cartridge, the time to partially mix before reaching the tip mixing element is even longer. This allows the viscosity of the components to be further reduced and the mixing elements to flow freely.
34. In yet another embodiment (Structure 4) for very viscous biomaterials, the mixing element is completely removed from the mixing shaft. In this embodiment, the components are mixed at a later stage, eg, a cannula device or other internal fracture fixation device such as a cannula mounting screw, nail, and pin. By removing all the mixing elements from the mixer, the biomaterial and the active ingredient can be partially but well mixed and their viscosity reduced before leaving the mixer. The cannula consists of a tubular tube with a base and tip, an inner diameter of 2.55 mm and an outer diameter of 3.5 mm (otherwise specified by the biomaterial used). At the proximal end, the cannula has a male luer lock that fits snugly into the female luer lock of the mixer. In addition, this end of the cannula has two wings that allow the surgeon to easily secure the cannula to the mixer. At the tip of the cannula, the last mixed biomaterial is dispensed from the complete device into the area of interest. The tip may have a rounded tip with a 1.5 mm opening or a flat tip with a 2.5 mm opening (otherwise specified by the biomaterial used). A flat tip is typically used when the mixing element is contained in the mixer. If the mixing element is not in the mixer, the mixing element is typically placed in the cannula. The rounded tip cannula in this case prevents the mixing elements from moving out of the cannula housing when the biomaterial and active ingredient are dispensed. The purpose of moving the mixed element from the mixer to the tip of the cannula is to allow the biomaterial and the active ingredient to reach the element together over a longer period of time. This allows the components to be partially mixed to reduce the viscosity and thus allow them to flow more freely through the mixing elements. In terms of design, reducing the inner diameter from the mixer to the cannula can help the partial mixing process with the turbulence generated at this portion. In addition, lower inner diameters increase the velocity of the components, which can reduce the overall pressure, as opposed to other systems described above. One of the main design features that generate pressure within the aforementioned system is the positioning of the mixing elements.
Positioning early in the process limits the reduction in component viscosity while creating a flow barrier before reaching the reduced inner diameter between the mixer and the cannula. This slows down the speed of the components in the system and thus increases the pressure. The working length of the cannula can be sized depending on the viscosity of the biomaterial and the requirements of the surgeon. Having a long working length cannula allows the biomaterial to mix with the active ingredient for a longer period of time before being dispensed into the area of interest. This also applies to all the systems mentioned above. In a system where the mixer does not have a mixing element and the cannula has a mixing element at the tip, a longer cannula can substantially reduce the viscosity of the components, thus increasing the surgeon's injectability.
35. The surgeon has the mixers of configurations 1 to 4 with a cannula to fill the bone voids, or multiple internal fracture fixation devices (ie, used without cannula parts) for exacerbation of signs of fixation trauma.
36. For internal fracture fixation devices such as screws, pins, nails, or equivalents, sheaths or sheath adapters (provided with internal fracture fixation devices) can be used to connect to each mixer configuration. The tip of the sheath is provided with a standard thread that allows the surgeon to screw the sheath clockwise to secure it onto the internal fracture fixation device. A female luer lock is provided at the base end of the sheath so that the sheath can be connected to the sheath adapter. The tip of the sheath adapter is located inside the base end of the sheath. When the sheath adapter is fixed in place by screwing it clockwise, the tip of the device projects beyond the tip of the sheath into the cannula opening at the proximal end of the internal fracture fixation device. The base end of the sheath adapter is a male luer lock capable of connecting the entire device (sheath, sheath adapter, and internal fracture fixation device) to any of the mixers 1 through 4.
37. In the mixers of configurations 1 to 3, mixing of the biomaterial with the active ingredient is completed before entering the sheath adapter and the internal fracture fixation device.
38. For the mixer of configuration 4, the mixing of the biomaterial and the active ingredient is complete upon entry into the internal fracture fixation device. In this design, the complete mixing process is further within the system by allowing the components to pass through the various shapes of the sheath adapter and the cannula-mounted internal fracture fixation device.
39. These shapes generate sufficient turbulence to evenly mix the components to provide the required cure time and compressive strength properties.
40. A method of delivering a biomaterial to a desired site using the biomaterial delivery system comprises the following steps.
(I) Assembling the biomaterial delivery system by performing the following steps:
(Ii) Attaching the cartridge (having two or more chambers) to the dispenser gun,
(Iii) Attaching the mixer to the cartridge (using a lure or similar lock attachment),
(Iii) Attaching the cannula or internal fracture fixing device (screws, nails, and pins) to the mixer.
41. A method of delivering a biomaterial to a desired site as described above, wherein the following device of the system delivers cement by activating the device using the steps of the method described above. The actuator typically comprises a hand-operated actuator trigger, typically pulling the trigger to activate the delivery device, the biomaterial and active ingredient being the mixer and cannula (needed). If), the curing reaction is started.
42. (Iii), the method of description 40, wherein the sheath is fixed to the internal fracture fixing device by screwing it clockwise. Place the tip of the sheath adapter inside the sheath from the upper end.
The internal fracture fixation device has a conduit that can extend along the longitudinal axis of the internal fracture fixation device, and the internal fracture fixation device fluidly communicates with the reservoir of the biomaterial so that the biomaterial comes out of the reservoir during use. It may be configured to be delivered through the mixer device and through the conduit of the internal fracture fixation device. In addition, the conduit is provided with an axial opening around the internal fracture fixing device so that the internal fracture fixing device is axially oriented and, if necessary, the internal fracture fixing device or the longitudinal axial direction. If it has a partially threaded configuration, it may be provided axially along the threaded ridge of the internal fracture fixation device.

All embodiments / configurations of the mixing system have the advantage that the system can mix the ingredients several times prior to delivery to the site of interest to meet the desired performance criteria.

As used herein, the term "comprising, including" specifies the existence of a property, integer, step, or component referred to, one or more other properties, integer, step, component, or them. Does not exclude the group of.

100 Dispenser Gun 101 Dispenser Gun Housing 102 Adjusted Slot for Cartridge 103 Trigger 104 Fixed Handle 105 Plunger 106 Plunger 107 Gripper Plate Tooth 108 Release Button 109 Second Slot 111 Gripper Plate Guide 112 Second Gripper Plate Guide 150 Dispenser Gun (Fig. 18)
200 Cartridge 201 First chamber of cartridge 200 202 Second chamber of cartridge 200 203 Base end of cartridge 200 204 Tip of cartridge 200 205 Stopper member 207 Foil seal, stopper, or seal with similar sealing means 209 From cartridge 200 Supply channel (exit)
211 Fixing member 213 Base 215 Cap 217 Channel seal 219 Guide notch 221 Cap housing 223 Cap handle 230 Piston 231 Piston housing 233 O-ring 235 Piston base end 237 Piston tip 239 Color 250 In another embodiment of the biomaterial reservoir It is in the form of a cartridge that has a reservoir, a longitudinal axis, and each has a generally long chamber.
251 Third chamber in the cartridge of another embodiment 300 Mixer 301 Mixer base end 302 Mixer tip 305 Luer lock 307 Mixing shaft 309 Mixing element 310 Another mixer 311 Injection channel 313 Guide notch 320 Another mixer 330 Another Mixer 500 Cannula 501 Base end 502 Tip 503 Luer lock 505 Wing 510 Partially threaded cannula mounting thread 512 Drilling thread 514 Assembly thread 515 Opening 530 Fully threaded cannula mounting screw 532 Thread for drilling 534 Thread for assembly 550 Sheath 551 Sheath adapter 552 Sheath female lure lock 555 Thread thread 554 Sheath adapter tip 555 Sheath tip 556 Sheath adapter male lure lock 557 Sheath adapter thread 558 Shown by virtual line Female thread on the sheath

Claims (43)

Dispenser devices configured to dispense biomaterials to desired sites, include actuators that can be operated to activate the dispenser device, and communicate fluidly with a reservoir containing the biomaterial.
A mixer device that is attachable to the reservoir and is configured to mix the biomaterial with any potentially necessary activator and is located in the mixing shaft and the inner cavity of the mixing shaft. With a mixer device having one or more mixed elements that have been
A biomaterial delivery system comprising a conduit attached to the mixer device that transports the biomaterial from the mixer device to the desired site of interest. The biomaterial delivery system of claim 1, wherein the conduit comprises a cannula or a cannula-mounted fracture fixation device. The dispenser device according to claim 1 or 2, further comprising an operable means for discharging the biomaterial and any active ingredient from the reservoir into the mixer device and the conduit for delivery to the desired site of interest. Biomaterial delivery system. The biomaterial delivery system according to any one of claims 1 to 3, wherein the dispenser device includes a reservoir for accommodating the biomaterial. The biomaterial delivery system according to any one of claims 1 to 4, wherein the reservoir comprises a cartridge that houses the biomaterial. The biomaterial delivery system of claim 5, wherein the dispenser device fits into the reservoir and comprises a reservoir locking means that holds the reservoir in place in the dispenser device. The biomaterial delivery system of claim 6, wherein the locking means comprises a slot configured to fit into the cartridge. 5. The dispenser device comprises a delivery gun and a housing of the delivery gun that rotatably supports an activation trigger that is operable to advance the plunger drive mechanism to release the biomaterial from the cartridge. Biomaterial delivery system. The biomaterial delivery system according to claim 8, wherein when the trigger is activated, the gripper plate is fitted into the drive mechanism, and the drive mechanism advances the plunger. The biomaterial delivery system of claim 8, wherein the dispenser device comprises a release button that allows the user to manually pull the plunger if necessary to remove the cartridge. The reservoir comprises a cartridge unit with a first chamber containing the biomaterial so that the cartridges house the biomaterial and the second material separately from each other until required at the surgical site. The biomaterial delivery system according to any one of claims 1 to 10, comprising a second chamber containing the material of 2. 11. The biomaterial delivery system of claim 11, wherein the cartridge comprises two or more chambers containing the biomaterial and the active ingredient separately from each other until required at the site of the surgery. The biomaterial delivery system according to claim 11, wherein the cartridge unit comprises three or more chambers depending on the formulation of the biomaterial. The biomaterial according to any one of claims 11 to 13, wherein each chamber is in the form of a tubular cross section having a generally elongated longitudinal axis, and the cylinder, or each cylinder has a proximal end and a distal end. Material delivery system. The biomaterial delivery system according to claim 14, wherein the cylinder or each cylinder comprises a piston approximately located at the proximal end of the cartridge. The biomaterial delivery system of claim 8, wherein the stopper member is located at the base end on the tubular wall of the cartridge to prevent the piston / plunger from being pushed out of the housing. 16. The biomaterial delivery system of claim 16, wherein a sealing means is provided at the base end of the cartridge to assist in sealing, and the surgeon can remove the seal prior to use of the cartridge. 11. The biomaterial delivery system of claim 11, wherein the cartridge has a tip, the tip of the cartridge comprising a plurality of supply channels for fluid communication with the mixer device. The biomaterial delivery system of claim 18, wherein the number of channels corresponds to the number of chambers contained in the cartridge unit, so that each chamber has its own channel for fluid communication with the mixer device. Each of the plurality of supply channels comprises one or more removable sealing means selected from ultrasonic welding, foil sealing, stopper caps, or similar sealing devices to provide sealing before use. The foil seal is configured to allow the biomaterial to be removed from each of the plurality of supply channels to expose the contents of any channel prior to placing the mixer device at the desired delivery site. The biomaterial delivery system according to claim 19. The reservoir comprises a cartridge containing the biomaterial, and all components of the cartridge are made from a medical grade polymeric material having the humidity / oxygen barrier properties required by the formulation of the biomaterial to be delivered. The biomaterial delivery system according to any one of claims 1 to 20. The biomaterial delivery system according to any one of claims 1 to 21, wherein the mixer device includes a tubular shaft having a proximal end and a distal end. 22. The biomaterial delivery system of claim 22, wherein the mixer device mates with the reservoir of biomaterial at one end and with a conduit for transporting the biomaterial to a desired delivery site at the other end. The mixer device comprises a mixing portion, and at the proximal end of the mixer device, the mixer device is fitted to the reservoir in the form of a cartridge so that the mixer device is connected to the reservoir. 23. The biomaterial delivery system of claim 23, comprising a connector configured to assist delivery of the biomaterial or active ingredient to said mixing. 24. The biomaterial delivery system of claim 24, wherein the interface between the cartridge and the mixer device is designed to provide a high quality seal that prevents loss / leakage of the biomaterial or active ingredient. A claim configured such that the tip of the mixer device is provided with locking means so that the delivery system can be connected to a cannula or other internal fracture fixation device such as a cannula mounting screw, nail, or pin. 25. The biomaterial delivery system. 25. The biomaterial delivery system of claim 25, wherein the mixer device comprises a mixing portion between the proximal end and the distal end of the mixer device. 28. The biomaterial delivery system of claim 27, wherein the mixing section comprises a mixing element configured to allow mixing of biomaterials of different viscosities. 28. The biomaterial delivery system of claim 28, wherein the mixed element comprises a spiral baffle or a similar mixed element. The biomaterial and the arbitrary active ingredient are mixed by moving the biomaterial through a mixing shaft that carries the biomaterial and the arbitrary active ingredient together, thereby initiating a curing (curing) reaction and dispensing. The biomaterial delivery system according to claim 28 or 29, wherein the required material is formed at the correct location and the user has complete control over the timing of the curing reaction. The biomaterial delivery system according to any one of claims 28 to 30, wherein the mixing element is located over substantially the entire length of the mixer device, and the mixing element is fixed to the base end of the mixer device. The biomaterial delivery system according to any one of claims 27 to 30, wherein the mixing shaft may contain a small number of mixing elements. The biomaterial delivery system according to any one of claims 27 to 30, wherein the mixing element is arranged so as to be freely movable along the entire length of the mixing shaft or substantially the entire length of the mixing shaft. The biomaterial delivery system according to any one of claims 27 to 30, wherein the mixed element can be fixed to the proximal end of the mixer device. The biomaterial delivery system according to any one of claims 27 to 30, wherein the extended mixer device comprises a small number of movable mixing elements. The mixing element is completely removed from the mixer device and the biomaterial is mixed at a later stage of the system, such as in a conduit, such as a cannula device, or a cannula mounting screw, nail, and pin. The biomaterial delivery system according to any one of claims 27 to 30, comprising another internal fracture fixation device. Dispenser devices configured to dispense biomaterials to desired sites, include actuators that can be operated to activate the dispenser device, and communicate fluidly with a reservoir containing said biomaterial.
A mixer device comprising a mixing portion between the base end and the tip end of the mixer device, wherein the mixing portion comprises a plurality of different mixing elements configured to allow mixing of biomaterials of different viscosities. With the device
A biomaterial delivery system comprising a conduit for transporting the biomaterial from the mixer device to the desired site of interest. 37. The biomaterial delivery system of claim 37, wherein the conduit comprises an internal fracture fixation device having a hollow hole forming a conduit for transporting the biomaterial from the reservoir to the desired delivery site. 38. The biomaterial delivery system of claim 38, wherein the internal fracture fixation device is configured to connect to a conduit with said mixing element. 38. The biomaterial delivery system of claim 38 or 39, wherein the internal fracture fixation device is configured to connect to a conduit with said mixing element using a sheath or sheath adapter. The biomaterial delivery system according to claim 40, wherein the sheath has a base end and a tip, and the tip of the sheath is provided with a connector for fitting the sheath to the internal fracture fixing device. The base end of the internal fracture fixing device has a cannula opening, and a connector configured to connect the sheath to the sheath adapter is provided at the tip of the sheath, and the tip of the sheath adapter is provided during use. When disposed within the proximal end of the sheath and the sheath adapter is inserted into the sheath, the distal end of the internal fracture fixation device penetrates the distal end of the sheath and the proximal end of the internal fracture fixation device. 41. The biomaterial delivery system according to claim 41, which projects into the cannula opening of the above. 42. The sheath adapter has a proximal end, the proximal end of the sheath adapter is a connector capable of connecting the entire device (sheath, sheath adapter, and internal fracture fixing device) to the mixer device. Biomaterial delivery system.

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